NMPA Holds Symposium on Medical Device Safety Enhancement Initiative

September 12th is the Day for the Prevention of Birth Defects. On this day in 2005, China and 1,500 scientists from countries around the world gathered at the Great Hall of the People in Beijing to share research findings on the prevention of birth defects and disabilities worldwide. At the meeting, the Chinese government decided to designate September 12th as "China's Day for the Prevention of Birth Defects" and proposed that the United Nations recognize it as the "World Day for the Prevention of Birth Defects." This year's theme is: Healthy Pregnancy, Protecting New Life. (Compiled by Ossd)

2. Mitral Valve Clip System Approved for Marketing

Recently, the National Medical Products Administration (NMPA) approved the registration of the innovative product "Mitral Valve Clip System" produced by Shanghai Hanyu Medical Technology Co., Ltd. after review. The product is designed for use in patients with degenerative mitral regurgitation (MR≥3+) who are assessed by a professional cardiac team as having high surgical risk and suitable mitral valve anatomy for the transapical approach. Underlying conditions in these patients should not affect the clinical benefits gained from reducing mitral regurgitation. The product’s market entry will provide more options for clinical treatment. (NMPA)

3. NMPA Holds Symposium on the Enhancement of Medical Device Safety

On the afternoon of July 7, a symposium on the enhancement initiative for medical device safety was held in Lanzhou. The meeting emphasized that carrying out the enhancement initiative for drug safety is a concrete practice to thoroughly implement the important instructions and comments of General Secretary Xi Jinping. Local areas should focus on prominent issues of concern to the people, with high standards, strict tones, and practical measures, to ensure greater achievements in the enhancement initiative and quality and safety special rectification. Efforts should be made to strengthen the advancement of systems and mechanism construction, continuously improve regulatory capacity and level, and strive to enhance the people's sense of gain. (National Medical Products Administration)

4. Hunan Province Drug and Medical Device GCP Inspector Training Course Held in Changsha

From the 5th to the 6th, the Hunan Provincial Drug Inspection and Verification Center held a GCP inspector training course for drugs and medical devices in Changsha. The conference indicated that the purpose of holding this GCP inspector training course for drugs and medical devices is to address the shortage of provincial GCP inspectors, the limited inspection capabilities, and the uneven development of drug and medical device clinical trial registration institutions, cultivating regulatory talent for quality management at clinical trial institutions in Hunan Province. The conference emphasized that integrity issues are fundamental to GCP inspectors, who must strictly enforce the provincial drug administration's regulations on party conduct and廉政 during inspections, ensuring fairness, impartiality, and integrity.

5. "Global Registration Pass" is a digital global registration management software for medical devices.

On the Path to Exploring Services in the Medical Device Field, Osmunda, the world’s leading service provider in the medical device industry, has discovered that medical device products are highly prone to issues during the registration phase. Reportedly, "Global Registration Express," a digital global registration management platform for medical devices pioneered by Osmunda, offers software services. With professional and systematic intelligent programs providing full-process guidance and tracking analysis, it significantly shortens time-to-market. Simple and easy to use, it is not only beginner-friendly but also enhances the ability of CRO teams to serve clients. By bringing the previously invisible registration progress online and making it visible, it becomes an effective tool for investors to manage their invested projects. (Compiled by Osmunda)

6. What are the main items checked in elderly health examinations?

Health Checkups for the Elderly Can Be Divided into Two Parts: General Items and Key Focus Areas, and Comprehensive Geriatric Assessment. In addition to routine checkup items, key focus areas include: ① Cardiovascular and cerebrovascular examination ② Cancer screening ③ Bone density testing ④ Other items: including blood glucose and lipid tests, fundus examination, gynecological examinations for women, and prostate checks for men. Comprehensive Geriatric Assessment: A multidisciplinary approach to evaluate the physical condition, functional status, mental health, and social environment of elderly individuals, and based on this, formulate a treatment plan aimed at maintaining and improving the health and functional status of the elderly, maximizing their quality of life. (Healthy China)

7. Scientists Develop Large Medical Models to Aid Diagnosis and Knowledge Sharing

Recently, a research team from Stanford University developed a large medical model based on vision and language to assist in medical diagnosis and knowledge sharing. In the paper, the researchers constructed a large dataset named OpenPath, which contains 208,414 pathology images, each paired with a natural language description. By developing the Pathology Language-Image Pre-training (PLIP) model, the researchers fully demonstrated the value of this resource. PLIP is a multimodal artificial intelligence model capable of understanding both images and text. Users can retrieve similar cases through image or natural language searches, greatly promoting knowledge sharing. (Ministry of Science and Technology)

8. Lanjia Medical Completes Tens of Millions of Yuan in Series A Financing, Accelerating the Launch of China-Made Intelligent Full Airway Management Tools

Recently, Lanjia Medical completed a multi-million yuan Series A round of financing, with investors being Zhangjiagang Shazhou Sci-Tech Innovation Investment Partnership (Limited Partnership) and Phoenix Technology. Shanghai Lanjia Medical Technology Co., Ltd., established in Shanghai in 2021, has developed into a strong integrated enterprise for the R&D, production, and sales of intelligent full airway management tools after two years of development, gaining popularity among a wide range of users, clinicians, and distributors. With the completion and commissioning of the company’s Suzhou production base, from 2023 to 2025, Lanjia Medical plans to register and mass-produce more than ten airway management products to comprehensively meet the needs of different types of users. (Vcbeat)